PIPELINE PED-400-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00847536015845), received between Mar 22, 2019 and Feb 5, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

11 other recalls cover devices cleared under the same FDA submission (P100018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jul 13, 2021Open, Classified

   Due to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube.

   Z-2402-2021 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2021Unintended Movement; Activation Failure; Physical Resistance/Sticking; Unintended Movement; Activation Failure; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED REPORTED THE PIPELINE POSITIONING WAS NOT IN A VESSEL BEND. THERE WAS NO FRICTION DURING DELIVERY. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11287748 ↗
• MalfunctionJan 14, 2021Break

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE PUSHWIRE DELIVERY BROKE AT THE TIP AFTER DEPLOYMENT. THERE WAS NO HARM TO THE PATIENT, AND THE WIRE BROKE AFTER IT WAS IN THE PHENOM 27 CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11175598 ↗
• MalfunctionNov 4, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE EXPERIENCED RESISTANCE DURING RESHEATHING, AND THE PHENOM 27 STRETCHED AND THE INNER LINER SEPARATED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN AMORPHOUS, UNRUPTURED ANEURYSM OF THE LEFT INTERNAL CAROTID ARTERY (ICA) WITH A MAX DIAMETER OF 7MM AND A 4MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED: LEFT ICA WIDE NECK ANEURYSM. IT WAS REPORTED THAT THE TRIAXIAL SUPPORT TECHNIQUE WAS USED WITH THE COOK SHUTTLE PLACED IN THE MID CERVICAL, THE PHENOM PLUS INTERMEDIATE IN THE LEFT ICA AT THE PETROUS SEGMENT, AND THEN THE PHENOM 27 PLACED AT THE PROXIMAL LEFT MIDDLE CEREBRAL ARTERY. THE PIPELINE WAS THEN DELIVERED AND MET HEAVY RESISTANCE UPON RESHEATH AFTER PIPELINE PLACEMENT CAME BACK PROXIMAL TO THE ANEURYSM. UPON REMOVING THE PHENOM 27 THROUGH THE PHENOM PLUS, IT SHOWED SIGNED OF STRETCHING. IT WAS REPORTED THE CATHETER WAS FLUSHED PER THE INSTRUCTIONS FOR USE (IFU), AND THERE WAS INNER LINER SEPARATION OF THE CATHETER IN THE DISTAL SEGMENT. DURING REMOVAL, THERE WAS NO FORCE APPLIED, THE CATHETER TIP WAS NOT ENTRAPPED/ST

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10788067 ↗
• MalfunctionSep 17, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event

  ***MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENTAL REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.***

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10551747 ↗
• InjuryNov 11, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  MEDTRONIC RECEIVED A REPORT OF PIPELINE FLEX PUSHWIRE SEPARATION. THE PATIENT WAS UNDERGOING TREATMENT FOR AN UNRUPTURED, SACCULAR ANEURYSM IN THE OPHTHALMIC ARTERY (ICA.) VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. DURING THE PROCEDURE, IT WAS REPORTED THAT THE PIPELINE FLEX BRAID WAS IMPLANTED WITHOUT ANY REPORTED ISSUES. IT WAS ALSO REPORTED THAT THE PIPELINE FLEX PUSHWIRE SEPARATED AT HYPOTUBE PROXIMAL TO WIRE WELD ("FROM THE RESHEATHING PAD UP"), AFTER THE PIPELINE WAS DEPLOYED. A RETRIEVAL DEVICE WAS USED TO REMOVE THE SEPARATED SEGMENT OF THE PUSHWIRE FROM THE PATIENT. THERE WERE NO REPORTS OF PATIENT SYMPTOMS IN ASSOCIATION WITH THIS EVENT. ANGIOGRAPHIC RESULTS POST-PROCEDURE WERE REPORTEDLY VERY GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9303083 ↗
• MalfunctionMay 24, 2019Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  MEDTRONIC RECEIVED A REPORT OF INTRAPROCEDURAL ANEURYSM RUPTURE DURING PIPELINE FLEX IMPLANTATION. PATIENT PRESENTED WITH A BLISTER ANEURYSM ON THE OPPOSITE WALL OF THE POSTERIOR COMMUNICATING ARTERY OF THE RIGHT ICA. VESSEL TORTUOSITY WAS DESCRIBED AS MODERATE. THE LANDING ZONE ARTERY SIZE WAS 3.24MM DISTAL AND 3.88MM PROXIMAL. IT WAS NOTED THAT THE PHYSICIAN HAD BEEN TRAINED TO PRE-DEPLOY THE PTFE PROTECTIVE SLEEVES ON THE BACK TABLE PRIOR TO DEPLOYMENT AND USED THIS METHOD DURING THIS PROCEDURE. IT WAS REPORTED THAT DURING THE PROCEDURE, A PIPELINE FLEX DEVICE WAS ATTEMPTED TO BE PLACED. THE DEVICE WAS "LAZY" TO OPEN ON THE DISTAL END. A CATHETER WAS ATTEMPTED TO BE NAVIGATED OVER THE WIRE, BUT RESISTANCE WAS EXPERIENCED. THE CATHETER WAS PULLED BACK. AN IMAGE WAS TAKEN, WHICH SHOWED AN ISSUE -- EITHER A PIPELINE FLEX TWIST, CLOT, OR RUPTURED ANEURYSM. A BALLOON WAS ADVANCED AND PASSED WITHOUT ISSUE; THE PHYSICIAN ELIMINATED THE POSSIBILITY OF PIPELINE FLEX TWIST. ULTIMATELY, TWO ADDITIONAL FLOW DIVERSION DEVICES WERE PLACED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8642751 ↗
• MalfunctionMar 22, 2019Activation Failure; Activation Failure

  MEDTRONIC RECEIVED INFORMATION THAT PIPELINE FLEX DEVICE DID NOT OPEN AT THE DISTAL END DURING THE PROCEDURE. THE PATIENT WAS UNDERGOING TREATMENT OF A SMALL UNRUPTURED SACCULAR RIGHT OPHTHALMIC ANEURYSM, MEASURING 8MM X 4MM. THE LANDING ZONE DISTAL WAS 3.7MM AND PROXIMAL WAS 4MM. THE VESSEL WAS REPORTEDLY MODERATELY TORTUOUS. THE DEVICES WERE PREPARED AS INDICATED IN THE IFU. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PIPELINE FLEX WAS DEPLOYED AND THE DISTAL SECTION WOULD NOT OPEN. MORE THAN 50% OF THE DEVICE HAD BEEN DEPLOYED WHEN THE ISSUE WAS OBSERVED. THE DEVICE HAD NOT BEEN PLACED IN A BEND. THE PHYSICIAN RESHEATHED AND RE-DEPLOYED THE DEVICE TWO TIMES WITH THE SAME RESULT. THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING A NEW DEVICE WITHOUT ISSUES. POST-PROCEDURE ANGIOGRAPHIC RESULT WAS GOOD. THERE WERE NO REPORTS OF PATIENT INJURY IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8444567 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P100018. One submission often covers many models, so check the product and lot details in each record.

• Z-1246-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-021-350-16, PED3-021-250-14, PED3-021-350-20, PED3-021-250-20, PED3-021-300-16, PED3-021-300-20, PE
• Z-1245-2025 · Jan 30, 2025 · Open, Classified
  Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14, PED3-027-350-16, PED3-027-350-20, PED3-027-350-25, PED3-027-400-12, PE
• Z-2403-2021 · Jul 13, 2021 · Open, Classified
  EV3 Pipeline Flex Embolization Device with Flex Shield Technology
• Z-1527-2020 · Feb 14, 2020 · Terminated
  ev3 Pipeline Flex Embolization Device. For neurological endovascular use.
• Z-0307-2017 · Oct 5, 2016 · Terminated
  Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracrani
• Z-0308-2017 · Oct 5, 2016 · Terminated
  Alligator Retrieval Device The device is intended for use in the peripheral and neurovasculature for foreign body removal. Catalog No. FA-88810-20V04 FA-88810-20V06 FA-88810-30V04
• Z-0309-2017 · Oct 5, 2016 · Terminated
  Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled
• Z-0310-2017 · Oct 5, 2016 · Terminated
  X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 10
• Z-0120-2016 · Sep 4, 2015 · Terminated
  -Pipeline Embolization Device -Pipeline Flex Embolization Device The Pipeline and Pipeline Flex Embolization Devices consist of a permanent implant combined with a guidewire based
• Z-1453-2014 · Apr 1, 2014 · Terminated
  Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
• Z-2045-2013 · Jul 19, 2013 · Terminated
  Pipeline Embolization Device (PED) The Pipeline Embolization Device is indicated for the endovascular treatment of adults (22 years of age and older) with large or giant wide-neck